Colonoscope-indicated for use within the lower recall: Contamination
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers…
Why was Colonoscope-indicated for use within the lower recalled?
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number (UDI-DI): PCF-H180AI (04953170339875), PCF-H180AL (04953170339899), PCF-H190DI (04953170363696), PCF-H190DL (04953170363672), PCF-H190I (04953170305214), PCF-H190L (04953170305191), PCF-H190TI (04953170420719), PCF-H190TL (04953170420702), PCF-HQ190I (04953170416132), PCF-HQ190L (04953170416118), PCF-PH190I (04953170305252), PCF-PH190L (04953170305238), PCF-Q180AI (04953170307713), PCF-Q180AL (04953170307720), PCF-S (04953170339912).
- Product
- Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers…
- Recalling firm
- Aizu Olympus Co., Ltd.
- Quantity
- 3101 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)